Depression MildIDECANCT05788198
Integrated Depression Care
A study testing Integrated care in people with Depression Mild and Depression Moderate, run by University Ghent at 2 sites in Belgium.
Trial summary
The Integrated DEpression CAre (IDECA) Programme is a multi-faceted intervention strategy aiming to improve guideline adherence and shared care practices for depression management in both providers and patients, as measured through a set of process and clinical outcome indicators (primary outcome measure). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression Mild, Depression Moderate, Depression Severe
- What is being tested?
- Integrated care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesBelgium
- Study dates
- 25 Apr 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- persons between 18-65
- presenting to the general practitioner's office
- with depressive symtomatology
Who cannot join
- Severe depression warranting direct referral to specialized services
- Inclusion criteria are kept broad on purpose as it's one of the research questions to define for which patients the intervention (namely the case management) is appropriate.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
ELZ Mechelen-Katelijne
Mechelen, 2800
Willy Heylen, MSc, 0474 69 54 05, willy.heylen@elzmechelenkatelijne.be
- Recruiting
ELZ Voorkempen
Zoersel, 2980
Lavinia Vervecken, MSc, +32(0)3 380 30 11, Lavinia.Vervecken@Emmaus.be
About this study
Official title: Integrated Depression Care Project
The Integrated DEpression CAre (IDECA) Programme is a multi-faceted intervention strategy aiming to improve guideline adherence and shared care practices for depression management in both providers and patients, as measured through a set of process and clinical outcome indicators (primary outcome measure).
Read the detailed description
The following deliverables apply:
- Development and implementation of a shared care protocol for depression management involving primary, secondary and tertiary care levels;
- Training module for physicians and other care providers in population health management for patients with depression;
- Training module for case managers/integration of a case management function into existing depression service offerings;
- A patient education module for depression self-management;
- A financing model for integrated depression care.
- Conditions
- Depression Mild, Depression Moderate, Depression Severe
- Being tested
- Integrated care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated careOther
The intervention will be modelled based on the most frequently reported patient, family physician and specialist barriers in depression management. In this project, multiple interventions aiming to tackle these barriers will be set up, with the WHO Framework on Integrated People-Centred Health Services (IPCHS) serving as conceptual backbone to the study (Table 1). The IPCHS distinguishes five interdependent strategies supporting a shift in healthcare delivery, management and funding towards universal health coverage. These strategies are:
- empowering and engaging people and communities;
- strengthening governance and accountability;
- reorienting the model of care;
- coordinating services within and across sectors;
- creating an enabling environment.
| Study group | Role | What they receive |
|---|---|---|
| Integrated care arm | Experimental | Case management in primary care setting (integration at general practitioners' practices), Depression and population management education for general practitioners, shared care guidance protocol including a medication path (drug classes, no specific drugs specified, based on available depression guidelines in Belgium). Receives: Other: Integrated care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention integration
Nomad questionnaire (4 monthly), followed by focus groups following Balint method, and individual interviews.
Measured: 14 months
Secondary outcomes (6)
Depression
PHQ-9 (Patient Health Questionnaire. DSM-5 depression), A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression
Measured: 12 months
Depression and anxiety
OQ-45-2 (Outcome Questionnaire. Transdiagnostical instrument focused on anxiety and depression) Total Score
- Total scores (≥ 64) reflect increased distress
- High is anything above 105
- Moderately High is between 83 and 105
- Moderate is between 64 and 82
- Low is anything below 64 Symptom Distress (SD)
- Scores (≥ 37) indicate subjective discomfort Interpersonal Relations (IR)
- Scores (≥ 16) reflect problems in interpersonal relations. Social Role (SR)
- Scores (≥ 13) indicate dissatisfaction, conflict, distress, and inadequacy in performance of tasks related to employment, school, family roles and leisure life.
Measured: 12 months
Medication adherence and self-efficacy
MARS-5 (Medication adherence report score) Each item was rated on a 5-point Likert scale, and the range of the MARS-5 total score is between 5 and 25. A higher score on the MARS-5 represents better medication adherence. <21 suboptimal adherence.
MUSE (Medication Understanding and Use Self-Efficacy Scale). Score 8-32. Higher scores are better.
Measured: 12 months
Resource use
iMCQ (The iMTA Medical Consumption Questionnaire) to capture depression-related resource use
Measured: 12 months
Health-related Quality of Life
EQ5D5L (EuroQol 5 Dimensions 5 levels). Score 0 equals death and 1 perfect health.
Measured: 12 months
Health literacy
HLS-EU-Q16. Considering the HLS-EUQ16 score, three levels of health literacy were defined: - inadequate HL (0-8) - problematic HL (9-12) - adequate HL (13-16)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start25 Apr 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre/Posttest implementation study.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen, Janssen-Cilag Ltd.
- Responsible party
- Sponsor
- Investigators
- Liesbeth Borgermans, PhD, Principal investigator, University GhentLieven Annemans, PhD, Study chair, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788198
- Sponsor's protocol ID
- NOPRODDEP4002
- Acronym
- IDECA
- Status last verified
- Jun 2024
- First submitted
- 19 Nov 2021
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: None, except anonymized data for peer review.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Depression Care Project
- ClinicalTrials.gov ID
- NCT05788198
- Acronym / sponsor ID
- IDECA / NOPRODDEP4002
- Conditions
- Depression Mild, Depression Moderate, Depression Severe
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen, Janssen-Cilag Ltd.
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Integrated DEpression CAre (IDECA) Programme is a multi-faceted intervention strategy aiming to improve guideline adherence and shared care practices for depression management in both providers and patients, as measured through a set of process and clinical outcome indicators (primary outcome measure).
Detailed description
The following deliverables apply:
- Development and implementation of a shared care protocol for depression management involving primary, secondary and tertiary care levels;
- Training module for physicians and other care providers in population health management for patients with depression;
- Training module for case managers/integration of a case management function into existing depression service offerings;
- A patient education module for depression self-management;
- A financing model for integrated depression care.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre/Posttest implementation study.
| Arm | Type | Receives |
|---|---|---|
| Integrated care arm | Experimental | Other: Integrated careCase management in primary care setting (integration at general practitioners' practices), Depression and population management education for general practitioners, shared care guidance protocol including a medication path (drug classes, no specific drugs specified, based on available depression guidelines in Belgium). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- persons between 18-65
- presenting to the general practitioner's office
- with depressive symtomatology
Key exclusion criteria (2 listed)
- Severe depression warranting direct referral to specialized services
- Inclusion criteria are kept broad on purpose as it's one of the research questions to define for which patients the intervention (namely the case management) is appropriate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated careThe intervention will be modelled based on the most frequently reported patient, family physician and specialist barriers in depression management. In this project, multiple interventions aiming to tackle these barriers will be set up, with the WHO Framework on Integrated People-Centred Health Services (IPCHS) serving as conceptual backbone to the study (Table 1). The IPCHS distinguishes five interdependent strategies supporting a shift in healthcare delivery, management and funding towards universal health coverage. These strategies are: 1. empowering and engaging people and communities; 2. strengthening governance and accountability; 3. reorienting the model of care; 4. coordinating services within and across sectors; 5. creating an enabling environment. | Other | Integrated care arm |
Primary outcome
Intervention integration
Time frame: 14 months
Nomad questionnaire (4 monthly), followed by focus groups following Balint method, and individual interviews.
6 secondary outcomes
Depression
Time frame: 12 months
Depression and anxiety
Time frame: 12 months
Medication adherence and self-efficacy
Time frame: 12 months
Resource use
Time frame: 12 months
Health-related Quality of Life
Time frame: 12 months
Health literacy
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No. None, except anonymized data for peer review.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liesbeth Borgermans, PhD principal investigator
University Ghent
Lieven Annemans, PhD study chair
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated care in people with Depression Mild and Depression Moderate, run by University Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruben P Willems, PhD (+32488307749, ruben.willems@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention integration (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.